Fluticasone propionate is a steroid having anti-inflammatory, anti-pruitic, and vasoconstrictive properties. Fluticasone propionate cream (0.05%) is sold under the tradename CUTIVATE® cream. Each gram of CUTIVATE® cream (0.05%) contains 0.5 mg fluticasone propionate in a base of propylene glycol, mineral oil, cetostearyl alcohol, ceteth-20, isopropyl myristate, buffers and preservatives.
Mineral oil is a known occlusive agent. Occlusion in topical drug delivery is known to increase the vasoconstrictor potency of the topical steroid. By increasing the vasoconstrictor potency, the effectiveness of the steroid is increased. However, occlusive agents such as mineral oil can reduce the aesthetic appeal of topical formulations as they may impart an undesirable oily feel to the skin. By removing or significantly reducing the concentration of the occlusive agent, a decrease in the vasoconstrictor potency of the steroid would be expected. Thus, the effectiveness of the topical steroid formulation would be decreased.
The present fluticasone lotion invention unexpectedly shows increased vasoconstrictor potency of fluticasone at decreased concentrations of occlusive agent, thus increasing the steroid effectiveness. The instant fluticasone lotion also significantly improves the organoleptic feel and spreadability of the drug over a large area as compared to a cream. Specifically, the instant fluticasone lotion has improved vasoconstrictor activity over fluticasone cream formulations. The fluticasone lotion is systemically safe and exhibits significant vasoconstrictor potency and efficacy and excellent anti-inflammatory activity.